定制式义齿企业现场检查主要问题的分析

Analysis of main issues in on-site inspection of customized denture enterprises

目的:分析国内定制式义齿生产企业质量管理体系现场检查发现的主要问题,对生产企业和医疗机构提出对策和建议。方法:对2018年国内多家定制式义齿生产企业现场检查发现的缺陷项目进行汇总、分类、归纳。结果:原食药监总局开展的7家企业飞行检查结果为2家企业停产整改、4家企业限期整改、1家企业检查前已停止生产。6家正常生产的企业合计发现缺陷88项,其中关键项目不符合要求的12项,一般项目不符合要求的76项。结论:生产企业应加强质量管理及与医疗机构的配合,监管部门应加强法规宣传和日常监管,确保规范得到正确贯彻实施。

Objective:Through analysis of the main problems existing in the quality management system of domestic customized denture manufacturers,and propose countermeasures and suggestions for production enterprises and medical institutions.Methods:The defections of several customized denture enterprises in 2018 were reviewed,and the main issues with the results of previous inspections were summarized.Results:The results of the unannounced inspections of the seven enterprises carried out by the NMPA were that 1)two enterprises had stopped production and rectification,2)four enterprises had been rectified within a time limit,and 3)one company had stopped production before inspection.A total of 88 deficiencies were found in 6 normal production enterprises,of which 12 critical deficiencies and 76 general deficiencies did not meet the requirements.Conclusions:Production enterprises should strengthen quality management and cooperation with medical institutions,and regulatory authorities should strengthen regulations and daily supervision,ensuring that GMP are properly implemented.